1. Health Technology Assessment (HTA)


Health Technology Assessment (HTA)

The reimbursement eligibility of new health technologies is assessed by the Health Technology Assessment (HTA) bodies in publicly funded health systems . HTA bodies evaluate health technologies from clinical, economic, ethical, legal, social, and organisational aspects following their respective frameworks, notably the “HTA Regulation” from 2021 [1] (see also Module 6 of the EUPATI Open Classroom). The HTA bodies appraise innovative health technologies using relevant evidence (generated from data) and issue recommendations based on this assessment to support national and regional policy makers in making informed decisions. Considering the structure of the health systems, the HTA frameworks and processes differ among the EU countries, and for digital health technologies /apps (DHTs) the assessing organisation must not even be an HTA body (see example below). However, with the increase in acceptance of DHTs, it is likely that there will be an increased number of HTA for DHTs. Given the novelty of these solutions, some HTA bodies may be unprepared to conduct comprehensive assessments of these technologies due to lack of experience and concerns about data quality. Therefore, HTA bodies will need to ensure appropriate expertise within their organisation around DHTs and frameworks to evaluate data when tasked to conduct these evaluations.


Germany has passed a law on digital health applications (DiGA [2]) that health applications certified as medical devices (class I or IIa according to the Medical Device Regulation (MDR)) and that have successfully completed the assessment of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) (essence of this assessment is the examination of the manufacturer’s statements about the product qualities – from data protection to user friendliness - and the examination of the evidence of the positive healthcare effect* of the DiGA provided by the manufacturer) leading to a listing in a directory of reimbursable digital health applications can be prescribed (Prescription is not required, but an official diagnosis is and depends upon approval from the health insurance. Despite an alternative non-prescription path to receive DiGA, clinicians are seen as the main gatekeeper in driving adoption.) and reimbursed by statutory health insurances [3] [4] [5].  

*A positive healthcare effect according to BfArM might be:

  • Medical benefits perceptible effects for a patient specifically regarding:
    • Improvement of the state of health
    • Shortening of the duration of the disease
    • Extension of survival
    • Improvement in the health-related quality of life.
  • Patient-relevant improvement of structure and processes in healthcare, supporting the health behaviour of patients or integrating the processes between patients and healthcare providers.

Might be one of the following:

      • Coordination of treatment procedures,
      • Alignment of treatment with guidelines and recognized standards,
      • Adherence,
      • Facilitating access to care,
      • Patient safety,
      • Health literacy,
      • Patient autonomy,
      • Coping with illness-related difficulties in everyday life, or
      • Reduction of the therapy-related efforts and strains for patients and their relatives.

Other European countries may have different procedures for reimbursement decisions for digital health apps [6].  


[1] Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282
[2] The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB VA Guide for Manufacturers, Service Providers and Users v.3.1, BfArM (2022).
[3] EunetHTA Joint Action 2 Work Package 8. HTA Core Model Version 3.0 for the Full Assessment of Diagnostic Technologies, Medical and Surgical Interventions, Pharmaceuticals and Screening Technologies.2016.
[4] O’Rourke B, Oortwijn W, Schuller T. The new definition of health technology assessment: A milestone in international collaboration. Int J Technol Assess Health Care. 2020;36(3):187-190. doi:10.1017/S0266462320000215.
[5] Research2guidance - The new digital health law in Germany – turning point or flash in the pan? Accessed June 25, 2022. https://research2guidance.com/the-new-digital-health-law-in-germany-turning-point-or-flash-in-the-pan/
[6] Recognising the value of digital health apps: An assessment of five European healthcare systems, Position paper, MedTech Europe (2021). Available at: 2111_v4.8_mte_dht_reimbursement16.11.2021-2.pdf (medtecheurope.org)